MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ D LM; UNKNOWN

Catalog Number 166576

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products- oxf cmntls implant insert , item 32-422097, lot # unknown.Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01237.

Event Description

It was reported that a patient underwent an initial knee procedure with oxford tibial implant in with the tibial holder.Unfortunately the wheel on the holder got stuck, the surgeon was unable to detach the implant from the holder and the tibial implant lifted back out with it creating a larger gap which the cementless tibia then would not fit back into at all.He then had to cement the tibia and used a cemented implant.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient underwent an initial knee procedure with oxford tibial implant in with the tibial holder.Unfortunately the wheel on the holder got stuck, the surgeon was unable to detach the implant from the holder and the tibial implant lifted back out with it creating a larger gap which the cementless tibia would not fit back into.Surgeon cemented the tibia and used a cemented implant.

• Brand Name: OXF UNI CMNTLS TIB SZ D LM
• Type of Device: UNKNOWN
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8134547
• MDR Text Key: 129591651
• Report Number: 3002806535-2018-01246
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 166576
• Device Lot Number: 6257675
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 62 YR